Changes & Trends in Solubilization Outsourcing

​By: Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc. ​Approved drugs over the last thirty-five years are evidence that there is a growing adoption of diverse solubilization technologies, with lipid followed by solid dispersion platforms appearing in the early 1980s, and nanocrystals emerging in the early 1990s.(1)An historic analysis of marketed drugs can be used to predict trends in the acceptance and utilization of these different platforms.Another approach is to analyze the changes in the business environment of service providers that support solubilization projects.

In our effort to gain insights into what is underway today, Agere conducted an analysis of the service providers that have offered solubilization solutions from formulation development through commercial manufacturing since the 1970s.Our study looked at market entry, market exit and consolidations of companies offering services in the following platforms: lipid/softgels, microparticles, nanoparticles, solid dispersions, and other miscellaneous technologies.This analysis utilized publically available information to compile all known companies involved in research, development and manufacturing in support of solubilization of third-party molecules as a service.(2)

Overall Growth in Number of Solubilization Service Providers

There has been a significant increase in the number of companies offering services to meet the solubilization needs of pharmaceutical and biotechnology companies over the past 35 years.A summary of some of our finding are presented in Figure 1.While a few companies such as RP Scherer were started many decades ago (1933), the majority of players emerge after the 1970s.In fact, between the 1980s and the current decade, the number of service providers in this market sub-segment has more than quadrupled.This growth is striking when taking into account the consolidation resulting from over 70 acquisitions and mergers during this same period.These activities both aggregated companies and also took some to be captive, removing them from our count of companies offering services to others.

Figure 1. ​

When looking at the number of unique companies by solubilization platform, we see trends that correlate with the findings from prior studies on marketed drugs and literature citations. Not surprisingly, softgel providers dominated in the two earliest decades in our analysis, and the number of companies has stayed relatively constant in this dynamic market segment. Starting in the first decade of this century, however, service providers in the solid dispersion sub-segment overtook the prior leader. Service provider companies utilizing solid dispersion platforms continues to grow in number, with over 25 players in the market as of today, now nearly twice as many as offering lipid-based solutions (Figure 2). ​

Figure 2.

As consolidation is a common route to growth for large companies, not surprisingly we have found that the largest CMOs in the solubilization space also have multiple platform offerings as a result of acquiring smaller, specialized companies.Additionally, and with few exceptions, it is the large organizations that clearly dominate the market share for the delivery platforms examined.This work also shows that those companies that are among the first to enter a particular market segment end up with the largest market share.(3)This trend is true for softgel, micronization, nanoparticles and solid dispersions.This finding is particularly interesting since even a short study of innovation diffusion shows that those with first-mover advantage often fail to capitalize on having been earliest to market, being displaced by more aggressive competitors even with lesser technology, or by providers offering a superior technical or economic solution. Yet our analysis doesn’t surface instances of note or supporting evidence of these vulnerabilities.

Looking Forward

Taking a snapshot of the solubilization sub-segment of the outsourcing market today reveals another potential clue regarding progress and potential.The number of companies offering solid dispersions dominates at40%, with lipid/softgels having the next highest number of unique companies and accounting for 20% of the total.The remaining two major categories each contribute 14%. Microparticles and nanoparticles account for 12% and 11%, respectively, with the number of service providers in nanoparticle platforms nearly tripling since the 1990s. The category of service providers not yet large enough to be categorized in the top four platforms (show as “Other” in Figure 3) has nearly tripled in number since the 1980s, but today accounts for only two-thirds of the percentage this category represented in that same decade. The fall in percentage could account for lack of traction of specific technologies, or assimilation into other companies and platforms over the last three decades. The rise in actual number in this miscellaneous subcategory could reflect the overall need for new and diverse approaches to tackle solubilization, and could possibly hold the seeds of emerging technologies that could move the industry forward in the coming years.

Figure 3.

Based on the dynamic nature of this market segment, no doubt the numbers will continue to shift. The accelerating growth and evolution of the solubilization services space is an indicator that we can expect to see new innovations in platforms, platform combinations and in business models in the years to come.

References1. http://drug-dev.com/Main/Back-Issues/BIOAVAILABILITY-ENHANCEMENT-Analysis-of-the-Histor-657.aspx 2. The analysis did not make a distinction between size of company, and companies regardless of the service or services provided – research, development, clinical trial materials manufacturing or commercial manufacturing – are weighed equally, and only accounted for once. 3. This includes companies that were dominant, even if now an acquired part of a larger CDMO. For more information, please visit www.agerepharma.com.